Managing Patient Context for Bedside Medical Devices – Today’s Situation

Clinical users have been managing patient context in various ways with medical devices for many years. With some classes of medical devices, this is nothing new.  So you might ask — what is the big deal here with patient context and what has changed that makes this topic relevant today?

As I stated in a previous post, managing patient context is all about the clinical workflow.  My working definition of patient context for medical devices is the linking of any information produced by a medical device (including data parameters, alarms, control settings, waveforms, etc.) with a specific patient identifier.

From a patient safety perspective, the best way to establish patient context is to tag data leaving a medical device with a unique patient identifier. And ideally this should be performed at the patient’s bedside where devices can come and go. There is clinician workflow associated with managing patient context – and this is perhaps the most important aspect.

We live in a dynamic world where technologies, products, and user requirements are constantly evolving. Take wireless medical devices for example. Wireless has evolved over the past few years and adoption will increase for the foreseeable future. When connectivity is wireless, patient context becomes even more challenging.  Another example is with the evolving requirements for automatically integrating device data in to an EMR. The EMR market is moving beyond relatively simple patient monitoring vital signs interfaces and is now looking to integrate all bedside device data including smart pumps.

If you look at what is quickly evolving at the point of care today, patient context is becoming more of a challenge for vendors that manufacture the medical devices and as a result, end users (clinicians) are being asked to perform the task of establishing patient context at the point of care. So let’s look at how patient context is currently managed (if at all) and the impact on workflow.

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Why Wireless Connectivity is Different

Wireless changes everything …

I have been watching the evolution of wireless bedside medical device connectivity for several years now. It is now fairly common for medical devices to communicate wirelessly and most hospitals now have the requisite Wi-Fi networks installed and operational. In fact, the saturation point of WLAN adoption in US hospitals has been reached as the numbers are quickly approaching 90% of all US hospitals.

But this posting is not about Wi-Fi or other wireless technologies used in medical devices. Rather it is about additional connectivity considerations beyond the actual wireless connection of the device to a network. Regardless of the wireless connection technology or standard used, wireless changes everything when it comes to connectivity.

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Barcoding and Patient Context

One of the most important areas of connectivity, and one that frequently does not receive the attention it deserves, is establishing and maintaining patient context. Historically, connected devices identified data by location – tagging data with a bed or even port number – rather than the actual patient name or ID. Because patients are frequently moved during an episode of care – not to mention ambulatory – data that is only tagged with a location presents risks of misidentification. In an effort to improve positive patient identification, data is increasingly tagged with a patient identifier.

Besides patient safety, patient context also greatly impacts medical device workflow. (Medical device connectivity is workflow automation through the integration of medical devices and information systems.) How a vendor implements patient context can have a big impact on usability and customer acceptance.

Patient context requirements can vary, based on the type of medical device in question. What is not variable is the requirement to reliably establish and maintain context. Mobile applications (like smart pumps or patient monitoring) where the device may go in and out of network coverage while constantly in use present special challenges. This compares to a fixed or portable medical device, like a dialysis machine or diagnostic ultrasound, with an episodic use case during which neither the device or patient is moved. Another variable is whether the application is life-critical. Continuous patient monitoring and many alarms (e.g., smart pumps and ventilators) are life-critical applications with a higher threshold of requirements. This contrasts with connectivity for documentation like with point of care testing or spot vital signs capture. In all cases though, patient context must be safe and reliable. The above issues just help define how many hoops you have to jump through to be safe and reliable.

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